Study Start-Up Associate

Study Start Up Associate / Submission Specialist / Study Start Up Lead - Hybrid - Sofia, Bulgaria

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

As a Study Start Up Associate II at ICON, you will lead the initiation of clinical trials, ensuring compliance with regulatory requirements, and contribute to the advancement of innovative treatments and therapies.

What You Will Do:

You will contribute to site start-up and activation activities, taking responsibility for your deliverables and working collaboratively.

Key responsibilities include:

• Leading the preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency communications.

• Coordinating and liaising with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation.

• Managing and maintaining comprehensive and accurate records of regulatory submissions, approvals, and correspondence

• Providing guidance and support to study teams on regulatory requirements and best practices for study start-up activities.

• Participating in process improvement initiatives to streamline study start-up processes and enhance efficiency.

Your Profile:

You will bring relevant site start-up and activation experience, along with the following qualifications and skills.

Required qualifications and experience:

• Bachelor's degree in life sciences or a related field.

• Minimum of 2 years of experience in clinical research or regulatory affairs, with specific experience in study start-up activities.

• Strong understanding of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulatory requirements.

• Excellent organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously.

• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.

• Willingness to travel as required (approximately 5%)

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Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

Are you a current ICON Employee? Please click here to apply